PDA Letter Article

Welcome New RAQAB Members

by Denyse Baker, Eli Lilly and Company

The Regulatory and Quality Advisory Board (RAQAB) started a new term in July with an updated leadership team, welcoming six new members. We would like to recognize and thank Jackie Veivia-Panter for her 13 years of service to the RAQAB. She has stepped down as Past Chair but remains active as a member of the ATMP Advisory Board, and we are happy to have her continue to serve as liaison between the two boards. Jackie continues to bring a narrow focus on PDA’s purpose and mission into any discussion and helps to drive strategic decision-making.

Anette Yan Marcussen has transitioned into the role of Past Chair and continues to be a champion for sharing regulatory intelligence to inform compliance and quality decision-making. Anette will assume primary responsibility for succession planning over the next two years. Denyse Baker is the new Chair, and we are very happy to welcome Eva Urban as the new Vice Chair of the RAQAB. Eva brings her quality risk management and quality systems expertise to this role and strong connections within the PDA Europe community.

As mentioned, we have six new members joining us from both big and small organizations, who bring diverse technical and geographic backgrounds as well as strong engagement across PDA. Several of them have already stepped up to also take on liaison roles to support RAQAB.

  • Vinny Browning – Exec. Dir, Quality, Amgen
  • Ursula Busse – Head Regulatory Affairs, Tigen Pharma SA
  • Beth Haas – Consultant, Haas Pharma Consulting
  • Hue Kwon – Global Head of Quality, VP Samsung
  • Demetra Macheras – Director, Regulatory Policy and Intelligence, AbbVie
  • Toni Manzano – Co-founder & CSO, Aizon

RAQAB continues to focus on raising the awareness of quality and regulatory expectations around the world as well as promoting harmonization wherever possible to streamline access for patients. In this current term, we have regional liaisons who bring in local updates and intelligence from Canada, Europe, Australia, Latin America, India, Singapore, Korea, China and the United States. We would like to highlight that for the upcoming 2023 PDA Quality and Regulations Conference in Antwerp, Nov 07 – 08. Co-chair Vinny Browning and planning committee members Hue Kwon and Eva Urban hope to see many of you there!

About the Author

Denyse BakerDenyse Baker is Associate Vice President, Global Quality Compliance with Eli Lilly and Company and a highly experienced leader in Quality and Regulatory Policy, Strategy and Advocacy. She is Chair of the PDA RAQAB, co-chair of the Quality Management Maturity Task Force and member of the PDA Sustainability Task Force.